Edentulous Jaws Partially Clinical Trial
Official title:
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Objectives: To compare the stability of implant surface treated by dual acid etching
(Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after
installation.
Methods: it will be a clinical study with individuals with missing teeth requiring
rehabilitation with dental implants in the maxilla and that fulfill the study inclusion
criteria. The research sites will be randomized into two groups: the control group patient's
sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant
Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque
Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability
of the implants will be made over 16 weeks, through resonance frequency analysis with
Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using
descriptive statistics and comparative.
| Status | Active, not recruiting |
| Enrollment | 42 |
| Est. completion date | |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - patients who have missing teeth in the maxilla, - over 30 years old and under 60 years old, - the implant sites with at least 3 months of healing after extraction, - the implant sites with width and length to installation of an implant of 4 mm x 10 mm. Exclusion Criteria: - patients who experience any of the following conditions: - general contraindications for surgical procedures, - uncontrolled diabetes, - severe bruxism or clenching, - pregnant and lactating women, - active periodontal disease, - smoker and user of alcohol or drugs. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Faculdade de Odontologia da USP | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | implant loss | During the osseointegration, if the implant lose his stability and if it show spin and if the patient have pain, the implant will be removed and the implant will be considered lost | 4 months | No |
| Secondary | ISQ analysis | Since the implant installation, for the next 8 weeks, and after for the next 4 months, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure | 6 months | No |